| Services | - International Compliance Management |
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Regulatory Facts - Japan
The more informed you are, the better prepared you will be
to gain market share in the global market. The below fact sheet provides general
fundamentals on gaining product approval in the targeted country.
Country Facts:
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Total
Population: 126,549,976 (July 2000 est) |
International
Organization Participation: APEC, OECD, IMF, WTO, etc… |
|
|
Health
Care Status: National |
Literacy
Rate: 99% (1970 est.) |
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Age Structure: |
0-14
yrs 15%
15-64
yrs 68% |
Primary
Industry: Electronics, Motor Vehicles, Machine Tools |
|
|
65 yrs
and over 17% |
GDP per
Capita: $34,283 (1999) |
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Communication
Status: Private (NTT, KDD, DDI, Japan Telecom, Teleway Japan, IDC,
etc) |
Males /
Females: 0.96 m/f |
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Government
Type:
Constitutional Monarchy |
Language:
Japanese |
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The three primary areas of
Telecommunications, Medical products, and Consumer products are addressed in
this Fact Sheet. For detailed information
on a specific country or product, please contact the International Compliance
Management Unit at TÜV SÜD Product Service at icm@tuvam.com .
|
Telecom |
Medical |
Consumer Products |
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Regulatory
Authority: Ministry
of Posts and Telecommunications Approval
Bodies: Japan
Approvals Institute for Telecommunications Equipment (JATE) |
Regulatory
Authority: Ministry
of Health and Welfare Approval
Bodies: Pharmaceutical
& Medical Device Examination Center (PMDEC) Japan
Association for the Advancement of Medical Equipment (JAAME) |
Regulatory
Authority: Ministry
of Economy, Trade and Industry Ministry
of International Trade and Industry Approval
Bodies: Third-party
certification by organizations such as JET or JQA |
|
EMC
& Safety: VCCI
(Voluntary) E mark |
Safety: E mark |
Safety: E mark S mark JIS mark
|
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Radio: Telecom
Engineering Center (TELEC) |
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Labeling:
A
specific label is required to be adhered to the approved product |
Labeling: A specific
label is required to be adhered to the approved product |
Labeling: A
specific label is required to be adhered to the approved product |
|
Residency
Requirements: A local
representative is required |
Residency
Requirements: A local representative
is required |
Residency
Requirements: A local
representative is required |
|
Current
Trends: 2.4 GHz
frequency hopping low power device approval – by both JATE and TELEC |
Currents
Trends: Roughly
90% of all applications are for “me-too” devices administered by JAAME |
Current
Trends: The
previous T mark system was replaced with the E mark system |
For more information, contact us.